Smart Pump Early Feasibility Study
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04465201|
Recruitment Status : Not yet recruiting
First Posted : July 10, 2020
Last Update Posted : July 10, 2020
|Condition or disease||Intervention/treatment||Phase|
|Cardiac Output||Device: Impella CP with Smart Assist (Circulatory Support System)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Advanced Impella® SmartAssist® System for Patient Monitoring & Treatment: An Early Feasibility Study|
|Estimated Study Start Date :||October 31, 2020|
|Estimated Primary Completion Date :||April 30, 2021|
|Estimated Study Completion Date :||April 30, 2021|
|Experimental: Subjects receiving the Impella/Impella® Hemodynamics platform||
Device: Impella CP with Smart Assist (Circulatory Support System)
Subjects will receive the Impella® with the Impella® Hemodynamics Platform prior to High risk percutaneous coronary intervention (HRPCI). Device escalation or early termination of the study will be allowed for subjects as deemed necessary by the treating physician. Subjects will be consented for follow-up through discharge from the index HRPCI admission.
- The ability to calculate and display cardiac output (CO). [ Time Frame: Through study completion, approximately 2 days ]Defined as the number of times a CO calibration sequence is successfully completed and the CO is displayed divided by the number of times the pinging sequence is attempted. The endpoint is a rate and therefore has no units of measure. It is the "number of times CO was successfully completed, and CO is displayed" divided by the "number of times the pinging sequence was attempted"
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04465201
|Contact: Samantha Polak, MD., PhD.||email@example.com|
|Contact: Adam Thompsonfirstname.lastname@example.org|